国产布南色林片与利培酮片治疗精神分裂症的多中心随机双盲双模拟平行对照临床试验

发布时间：2018-04-01 04:46

本文选题：布南色林　切入点：利培酮　出处：《中国新药杂志》2016年07期

【摘要】：目的:评价国产布南色林治疗急性精神分裂症的疗效及安全性。方法:采用随机双盲多中心活性药对照研究方法。将298例18~65岁急性精神分裂症患者随机分为布南色林组(n=148,8~24 mg·d-1)和利培酮组(n=150,2~6 mg·d-1),疗程8周。以阳性和阴性症状量表(PANSS)总分变化为疗效指标。结果:布南色林组PANSS总分从基线的93.99分降至62.24分,利培酮组从基线的92.09分降至58.67分,平均减分分别为31.74和33.43分。布南色林组和利培酮组的有效率分别为58.11%和64.67%,不良事件发生率分别为78.38%和86.67%。布南色林组对体质量和血清泌乳素的影响较小。结论:国产布南色林治疗急性精神分裂症的疗效非劣于利培酮,不良反应相似。但是,布南色林较少引起患者体质量增加,对血清泌乳素水平影响较小。
[Abstract]:Objective: to evaluate the efficacy and safety of domestic bunanserin in the treatment of acute schizophrenia. Methods: 298 patients with acute schizophrenia aged 1865 were randomly divided into Bunam by randomized double-blind multicenter active drug control study. Results: the total score of PANSS was decreased from 93.99 to 62.24 in the penicillin group and in the risperidone group for 8 weeks. The total score of the positive and negative symptom scale was used as the index of curative effect, and the results showed that the total score of PANSS decreased from 93.99 to 62.24 in the Bunanserin group, and the results showed that the total score of PANSS was decreased from 93.99 to 62.24 in the penicillin group and in the risperidone group for 8 weeks. The risperidone group decreased from 92.09 at baseline to 58.67 at baseline. The effective rate of Bunanserin group and risperidone group were 58.11% and 64.677.The incidence of adverse events were 78.38% and 86.67%, respectively. The effect of Bunanserin group on body mass and serum prolactin was small. Conclusion:. The efficacy of bugenserin in the treatment of acute schizophrenia is not inferior to that of risperidone. The adverse reactions were similar. However, less Bunanserin caused an increase in body mass and had little effect on serum prolactin levels.
【作者单位】：北京大学第六医院北京大学精神卫生研究所卫生部精神卫生学重点实验室(北京大学);北京回龙观医院;首都医科大学附属北京安定医院;天津市安定医院;河北省精神卫生中心;广州市精神病医院;无锡市精神卫生中心;昆明医学院第一附属医院;四川大学华西医院;第四军医大学卫生统计学教研室;
【分类号】：R749.3

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